Canada opens up to new data on probiotics

Rupika Malhotra, MSc

Fri, 2012-04-06 13:21

The NHPD is said to be accepting data with regards to currently identified live microorganisms species that can be classified as probiotics based on conferred health benefits. They have stated that the probiotics monograph and associated regulations will be revisited and updated should viable human clinical data be presented.

Probiotics are defined as “live microorganisms which when administered in adequate amounts confer a health benefit on the host.” This definition in conjunction with what seems to be a lack of substantial human clinical evidence with regards to strain specific efficacy is the present basis upon which the Natural Health Products Directorate (NHPD) has chosen to modify and update current probiotic regulations.

Presently, the regulations dictate that probiotic identity and claims are permitted on 3 exclusive species: Lactobacillus johnsoii La1 / Lactobacillus johnsoii Lj1/ Lactobacillus johnsoii NCC 533, Lactobacillus rhamnosus GGandSaccharomyces boulardii. All other strains must be identified and marketed as Live Microorganisms with the claims limited to the following statement “Provides live microorganisms that temporarily modify gut flora.”

The NHPD is said to be accepting data with regards to currently identified live microorganisms species that can be classified as probiotics based on conferred health benefits. They have stated that the probiotics monograph and associated regulations will be revisited and updated should viable human clinical data be presented. The Food Directorate branch of Health Canada is also suspected to implement the same requirement for strain specific evidence with regards to probiotics use. It should be noted that as of yet no strain specific claims have been approved for use in Canada.

These changes can produce a potential road block for small scale natural health product companies as some have argued that innovation and growth are being hindered. However, one could also argue that the need for future research within this field will allow for a stronger understanding of probiotics in the human gut in addition to creating more unexplored avenues for the natural health products and food industry.